Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Boryung Pharmaceutical Co., Ltd36 enrolled

Overview

The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-Drug Interaction

Interventions

Fimasartan/Amlodipine combination drug, HydrochlorothiazideDRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A healthy Male adults aged 19-50 years Exclusion Criteria: * History or presence of clinically significant medical or psychiatric condition or disease. * Hypersensitivity to ingredient of IP and other medication, food. * Participation in any other study within 3months. * History of whole blood donation within 2months and Apheresis 1month.

Locations (1)

Inje University Busan Paik Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Cmax

Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Time frame: 0~48hours after medication

Secondary Outcomes

AUCt

AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide

Time frame: 0~48hours after medication

Data from ClinicalTrials.gov

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